Description
In recent years the pharmaceutical industry has responded to an increased demand for drug products which are packaged for "unit dose" dispensing, i.e. the delivery of a single dose of a drug to the patient at the time of administration for institutional use, e.g., hospitals. The drug product is dispensed in a unit dose container--a non-reusable container designed to hold a quantity of drug intended for administration (other than the parenteral route) as a single dose, directly from the container, employed generally in a hospital unit dose system. The advantages of unit dose dispensing are that the drug is fully identifiable and the integrity of the dosage form is protected until the actual moment of administration. If the drug is not used and the container is intact, the drug may be retrieved and redispensed without compromising its integrity.
Scope & Applicability
Product Classes
1non-reusable container designed to hold a quantity of drug intended for administration as a single dose
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Property of a device that may be changed via established protocols
Related CFR Sections (2)
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
Related Warning Letters (5)
- 2025-01-28
Unapproved New Drugs/Misbranded
Mihon Corp. d/b/a VitalityVita and Boulla, LLC
- 2023-12-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
East Fork Cultivars
- 2023-03-14
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
ElectRx and Health Solutions, LLC
- 2023-01-17
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
HIS Enterprise Inc dba Adam’s Secret USA, LLC
- 2020-01-28
Unapproved New Drugs/Misbranded
Wave Miami LLC
See Also (8)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry (Status: Draft)
- Labeling for Biosimilar and Interchangeable Biosimilar Products (Status: Draft)
- Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (Status: Draft)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (Status: Final)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)